A Phase 2 Study to Assess the Safety and Efficacy of TGR‐1202 in Patients with Chronic Lymphocytic Leukemia (CLL) who are Intolerant to Prior BTK or PI3K‐Delta Inhibitor Therapy

This is a Phase 2, open-label, study of TGR-1202, a PI3K delta inhibitor, administered as a single agent in Chronic Lymphocytic Leukemia (CLL) patients who are intolerant to prior BTK inhibitors (ibrutinib, other) or prior PI3K delta inhibitors (idelalisib, other)


Cancer (Oncology) - Leukemia, Cancer (Oncology)
John Pagel, MD, PhD
Swedish Cancer Institute
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL)
  • Discontinuation on prior BTK inhibitor or PI3K delta inhibitor due to adverse events within prior 9 months
  • Presence of measurable disease

Exclusion Criteria:

  • Progression on prior BTK or PI3K delta inhibitor
  • Prior treatment with TGR-1202
  • Richter's transformation or CLL transformation to aggressive lymphoma
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